Skip to main content
Clinical Trials/NCT07503522
NCT07503522RecruitingNot Applicable

Evaluation of the Effectiveness of a Personalized Music-Based Aerobic Exercise Rehabilitation Program for Patients With Subacute Stroke

Trịnh Minh Tú1 site in 1 country92 target enrollmentStarted: April 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
92
Locations
1
Primary Endpoint
Change in Fugl-Meyer Upper Extremity (FMA-UE) Score

Study Overview

Brief Summary

This study aims to evaluate the effectiveness of a personalized music-based aerobic exercise program designed specifically for inpatients in the subacute phase of stroke. All participants will receive the hospital's standard physical therapy program. In addition, the intervention group will participate in 30-minute music-based aerobic exercise sessions, 5 days per week, for a total of 6 weeks.

The aerobic exercises are gentle and adapted to the functional abilities of individuals with subacute stroke. The exercises incorporate rhythmic music to guide movements of the arms, legs, and trunk, with the goal of improving mobility, balance, and mood. Participants will have their heart rate monitored and will be supervised directly by rehabilitation therapists throughout all sessions to ensure safety.

Outcomes will be assessed before and after the 6-week intervention using standardized measures of motor function, balance, depressive symptoms, and independence in daily activities. The study does not interfere with participants' routine medical treatment and does not require discontinuation of any ongoing therapies.

Risks associated with participation are generally mild and similar to those of routine therapeutic exercise, such as muscle soreness, dizziness, or risk of falls. All potential risks will be minimized through continuous supervision by trained healthcare staff. Participants may withdraw from the study at any time.

Potential benefits for participants include improved mobility, better balance, reduced depressive symptoms, increased independence in daily living, and enhanced motivation during rehabilitation through the use of music. The study also aims to provide scientific evidence for the effectiveness of music-based aerobic exercise in stroke rehabilitation in Vietnam.

Detailed Description

Subacute stroke represents a critical window for neurological recovery, during which neuroplasticity is heightened and rehabilitation interventions may have a stronger impact on long-term functional outcomes. Despite receiving standard inpatient rehabilitation, many patients continue to experience persistent limitations in mobility, balance, and emotional well-being. There is growing evidence that aerobic exercise can enhance neuroplasticity, improve cardiovascular fitness, and support motor relearning during stroke recovery. Music-based rehabilitation approaches, including rhythmic auditory stimulation, have also been shown to facilitate coordinated movement, increase engagement, and positively influence mood.

However, most aerobic exercise protocols studied internationally-such as treadmill walking, stationary cycling, or moderate-to-high intensity regimens-are not feasible for many patients in the subacute phase because of weakness, impaired balance, or restricted mobility. There is a need for accessible, adaptable, and lower-intensity aerobic interventions that can be delivered safely during inpatient rehabilitation without requiring specialized equipment.

This study was designed to address this gap by developing a structured music-based aerobic exercise program tailored to the physical capacity of individuals with subacute stroke. The intervention incorporates rhythmic music with clear tempo cues to support timing, pacing, and coordination of limb and trunk movements. The exercise sequence includes warm-up, rhythmic aerobic movements, and cool-down, and may be performed in either a seated or supported standing position depending on each participant's functional ability. Music selections are chosen to provide stable rhythm, moderate tempo, and a motivating emotional tone, which may enhance participation and therapeutic engagement.

The trial uses a randomized controlled design to investigate whether adding this structured music-based aerobic program to standard inpatient rehabilitation produces additional improvements over a 6-week period. The conceptual foundation for this intervention draws from principles of neurologic music therapy, aerobic conditioning guidelines for individuals post-stroke, and emerging evidence that music can improve movement synchronization, attentional focus, and emotional regulation.

Safety is an integral component of the study design. The intervention was created specifically to avoid complex or destabilizing movements and to remain within a mild-to-moderate intensity range appropriate for subacute stroke patients. Continuous supervision by rehabilitation therapists and monitoring of vital signs aim to ensure that the program remains safe and well tolerated. The study also includes procedures for identifying, documenting, and managing adverse events and for adjusting the protocol as necessary to maintain participant safety.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years.
  • Clinically and radiologically confirmed diagnosis of subacute stroke.
  • Able to understand and respond to assessment questions.
  • No significant visual or hearing impairment.
  • Mini-Mental State Examination (MMSE) ≥
  • Able to sit unsupported.
  • Provided informed consent (patient or legal representative).

Exclusion Criteria

  • Recent myocardial infarction or congestive heart failure.
  • Severe cardiac arrhythmia or resting systolic blood pressure > 200 mmHg.
  • Hypertrophic cardiomyopathy or severe aortic stenosis.
  • Musculoskeletal disorders contraindicating exercise.
  • Psychiatric disorders interfering with participation.
  • Severe aphasia preventing assessment.
  • Moderate-to-severe dementia (MMSE ≤ 9).

Arms & Interventions

Control Group: Standard Physical Therapy

Active Comparator

Participants in the control arm will receive the standard inpatient physical therapy program routinely applied at the hospital. The standard physical therapy includes assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy exercises for activities of daily living (30 minutes per session). Training is conducted by certified physiotherapists, 1 session/day, 5 days/week, for 6 consecutive weeks during hospitalization. No aerobic exercise with music is provided in this arm.

Intervention: Standard Physical Therapy (Behavioral)

Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy

Experimental

Participants receive the standard inpatient physical therapy program, including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes/session), and occupational therapy for activities of daily living (30 minutes/session). In addition, they complete a 30-minute supervised aerobic exercise program with music, 1 session/day, 5 days/week for 6 weeks. Exercises include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, and supported standing arm lifts, trunk rotation, high-knee marching, and step-forward/back drills. Music tempo is phase-specific: warm-up 60-70 bpm, main session 80-110 bpm, cool-down 50-60 bpm. Heart rate is monitored with a smart wristband, with intensity limited to 60% of the individual target heart rate calculated using the Karvonen formula.

Intervention: Standard Physical Therapy (Behavioral)

Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy

Experimental

Participants receive the standard inpatient physical therapy program, including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes/session), and occupational therapy for activities of daily living (30 minutes/session). In addition, they complete a 30-minute supervised aerobic exercise program with music, 1 session/day, 5 days/week for 6 weeks. Exercises include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, and supported standing arm lifts, trunk rotation, high-knee marching, and step-forward/back drills. Music tempo is phase-specific: warm-up 60-70 bpm, main session 80-110 bpm, cool-down 50-60 bpm. Heart rate is monitored with a smart wristband, with intensity limited to 60% of the individual target heart rate calculated using the Karvonen formula.

Intervention: Aerobic Exercise With Music (Behavioral)

Outcomes

Primary Outcomes

Change in Fugl-Meyer Upper Extremity (FMA-UE) Score

Time Frame: 6 weeks after intervention

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluates motor function, coordination, reflexes, sensation, joint pain, and passive joint motion. Scores range from 0 to 126, with higher scores reflecting better motor recovery. This primary outcome measures the change in total FMA-UE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).

Change in Fugl-Meyer Lower Extremity (FMA-LE) Score

Time Frame: 6 weeks after intervention

The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) evaluates reflexes, motor control of the hip, knee, and ankle, coordination, sensation, joint pain, and passive joint motion. Scores range from 0 to 86, with higher scores indicating better lower-limb motor recovery. This primary outcome measures the change in total FMA-LE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).

Secondary Outcomes

  • Change in Barthel Index Score(6 weeks after intervention)
  • Change in PHQ-9 Depression Score(6 weeks after intervention)
  • Change in Berg Balance Scale (BBS) Score(6 weeks after intervention)
  • Change in NIH Stroke Scale (NIHSS) Score(6 weeks after intervention)
  • Change in Mini-Mental State Examination (MMSE) Score(6 weeks after intervention)
  • Exercise-Related Adverse Events(During the 6-week intervention)

Investigators

Sponsor
Trịnh Minh Tú
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Trịnh Minh Tú

Specialist Level II Physician, Department of Physical Medicine and Rehabilitation

University of Medicine and Pharmacy at Ho Chi Minh City

Study Sites (1)

Loading locations...

Similar Trials